the community pressure group campaigning to
keep Wales free of genetically-modified crops

GM-Free Cymru

Literature

Revealed -- How The American FDA Promotes GM Foods

An FDA-Created Health Crisis Circles the Globe

How corporations engineered the non-regulation of dangerous genetically modified
foods

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Government officials around
the globe have been coerced, infiltrated, and paid off by the agricultural
biotech giants. In Indonesia, Monsanto gave bribes and questionable payments
to at least 140 officials, attempting to get their genetically modified (GM)
cotton approved. [1] In India, one official tampered with the report on Bt
cotton to increase the yield figures to favor Monsanto. [2] In Mexico, a senior
government official allegedly threatened a University of California professor,
implying “We know where your children go to school,” trying to
get him not to publish incriminating evidence that would delay GM approvals.
[3] While most industry manipulation and political collusion is more subtle,
none was more significant than that found at the US Food and Drug Administration
(FDA).

The FDA’s “non-regulation” of GM foods

Genetically modified crops are the result of a technology developed in the
1970s that allow genes from one species to be forced into the DNA of unrelated
species. The inserted genes produce proteins that confer traits in the new
plant, such as herbicide tolerance or pesticide production. The process of
creating the GM crop can produce all sorts of side effects, and the plants
contain proteins that have never before been in the food supply. In the US,
new types of food substances are normally classified as food additives, which
must undergo extensive testing, including long-term animal feeding studies.
[4] If approved, the label of food products containing the additive must list
it as an ingredient.

There is an exception, however, for substances that are deemed “generally
recognized as safe” (GRAS). GRAS status allows a product to be commercialized
without any additional testing. According to US law, to be considered GRAS
the substance must be the subject of a substantial amount of peer-reviewed
published studies (or equivalent) and there must be overwhelming consensus
among the scientific community that the product is safe. GM foods had neither.
Nonetheless, in a precedent-setting move that some experts contend was illegal,
in 1992 the FDA declared that GM crops are GRAS as long as their producers
say they are. Thus, the FDA does not require any safety evaluations or labels
whatsoever. A company can even introduce a GM food to the market without telling
the agency.

Such a lenient approach to GM crops was largely the result of Monsanto’s
legendary influence over the US government. According to the New York Times, “What
Monsanto wished for from Washington, Monsanto and, by extension, the biotechnology
industry got. . . . When the company abruptly decided that it needed to throw
off the regulations and speed its foods to market, the White House quickly
ushered through an unusually generous policy of self-policing.” According
to Dr. Henry Miller, who had a leading role in biotechnology issues at the
FDA from 1979 to 1994, “In this area, the U.S. government agencies have
done exactly what big agribusiness has asked them to do and told them to do.”

Following Monsanto’s lead, in 1992 the Council on Competitiveness chaired
by Vice President Dan Quayle identified GM crops as an industry that could
increase US exports. On May 26, Quayle announced “reforms” to “speed
up and simplify the process of bringing” GM products to market without “being
hampered by unnecessary regulation.” [5] Three days later, the FDA policy
on non-regulation was unveiled.

The person who oversaw its development was the FDA’s Deputy Commissioner
for Policy, Michael Taylor, whose position had been created especially for
him in 1991. Prior to that, Taylor was an outside attorney for both Monsanto
and the Food Biotechnology Council. After working at the FDA, he became Monsanto’s
vice president.

Covering up health dangers

The policy he oversaw needed to create the impression that unintended effects
from GM crops were not an issue. Otherwise their GRAS status would be undermined.
But internal memos made public from a lawsuit showed that the overwhelming
consensus among the agency scientists was that GM crops can have unpredictable,
hard-to-detect side effects. Various departments and experts spelled these
out in detail, listing allergies, toxins, nutritional effects, and new diseases
as potential problems. They had urged superiors to require long-term safety
studies. [6] In spite of the warnings, according to public interest attorney
Steven Druker who studied the FDA’s internal files, “References
to the unintended negative effects of bioengineering were progressively deleted
from drafts of the policy statement (over the protests of agency scientists).” [7]

FDA microbiologist Louis Pribyl wrote about the policy, “What has happened
to the scientific elements of this document? Without a sound scientific base
to rest on, this becomes a broad, general, ‘What do I have to do to avoid
trouble’-type document. . . . It will look like and probably be just
a political document. . . . It reads very pro- industry, especially in the
area of unintended effects.” [8]

The FDA scientists’ concerns were not only ignored, their very existence
was denied. Consider the private memo summarizing opinions at the FDA, which
stated, “The processes of genetic engineering and traditional breeding
are different and according to the technical experts in the agency, they lead
to different risks.” [9] Contrast that with the official policy statement: “The
agency is not aware of any information showing that foods derived by these
new methods differ from other foods in any meaningful or uniform way.” [10]
On the basis of this manufactured and false notion of no meaningful differences,
the FDA does not require GM food safety testing.

To further justify their lack of oversight, they claimed that GM crops were “substantially
equivalent” to their natural counterparts. But this concept does not
hold up to scrutiny. The Royal Society of Canada described substantial equivalence
as “scientifically unjustifiable and inconsistent with precautionary
regulation of the technology.” In sharp contrast to the FDA’s position,
the Royal Society of Canada said that “the default prediction” for
GM crops would include “a range of collateral changes in expression of
other genes, changes in the pattern of proteins produced and/or changes in
metabolic activities.” [11]

Fake safety assessments

Biotech companies do participate in a voluntary consultation process with
the FDA, but it is derided by critics as a meaningless exercise. Companies
can submit whatever information they choose, and the FDA does not conduct or
commission any studies of their own. Former EPA scientist Doug Gurian-Sherman,
who analyzed FDA review records obtained through the Freedom of Information
Act, states flatly, “It is clear that FDA’s current voluntary notification
process (even if made mandatory) is not up to the task of ensuring the safety
of future GE [genetically engineered] crops.” He says, “The FDA
consultation process does not allow the agency to require submission of data,
misses obvious errors in company-submitted data summaries, provides insufficient
testing guidance, and does not require sufficiently detailed data to enable
the FDA to assure that GE crops are safe to eat.” [12] Similarly, a Friends
of the Earth review of company and FDA documents concluded:

“If industry chooses to submit faulty, unpublishable studies, it does
so without consequence. If it should respond to an agency request with deficient
data, it does so without reprimand or follow-up. . . . If a company finds it
disadvantageous to characterize its product, then its properties remain uncertain
or unknown. If a corporation chooses to ignore scientifically sound testing
standards . . . then faulty tests are conducted instead, and the results are
considered legitimate. In the area of genetically engineered food regulation,
the ‘competent’ agencies rarely if ever (know how to) conduct independent
research to verify or supplement industry findings.” [13]

At the end of the consultation, the FDA doesn’t actually approve the
crops. Rather, they issue a letter including a statement such as the following:

“Based on the safety and nutritional assessment you have conducted,
it is our understanding that Monsanto has concluded that corn products derived
from this new variety are not materially different in composition, safety,
and other relevant parameters from corn currently on the market, and that the
genetically modified corn does not raise issues that would require premarket
review or approval by FDA. . . . As you are aware, it is Monsanto’s responsibility
to ensure that foods marketed by the firm are safe, wholesome and in compliance
with all applicable legal and regulatory requirements.” [14]

The National Academy of Sciences and even the pro-GM Royal Society of London
[15] describe the US system as inadequate and flawed. The editor of the prestigious
journal Lancet said , “It is astounding that the US Food and Drug Administration
has not changed their stance on genetically modified food adopted in 1992.
. . . The policy is that genetically modified crops will receive the same consideration
for potential health risks as any other new crop plant. This stance is taken
despite good reasons to believe that specific risks may exist. . . . Governments
should never have allowed these products into the food chain without insisting
on rigorous testing for effects on health.” [16]

Promoting and regulating don’t mix

The FDA and other regulatory agencies are officially charged with both regulating
biotech products and promoting them—a clear conflict. Suzanne Wuerthele,
a US EPA toxicologist, says, “This technology is being promoted, in the
face of concerns by respectable scientists and in the face of data to the contrary,
by the very agencies which are supposed to be protecting human health and the
environment. The bottom line in my view is that we are confronted with the
most powerful technology the world has ever known, and it is being rapidly
deployed with almost no thought whatsoever to its consequences.”

Canadian regulators are similarly conflicted. The Royal Society of Canada
reported that, “In meetings with senior managers from the various Canadian
regulatory departments . . . their responses uniformly stressed the importance
of maintaining a favorable climate for the biotechnology industry to develop
new products and submit them for approval on the Canadian market. . . . The
conflict of interest involved in both promoting and regulating an industry
or technology . . . is also a factor in the issue of maintaining the transparency,
and therefore the scientific integrity, of the regulatory process. In effect,
the public interest in a regulatory system that is ‘science based’—that
meets scientific standards of objectivity, a major aspect of which is full
openness to scientific peer review—is significantly compromised when
that openness is negotiated away by regulators in exchange for cordial and
supportive relationships with the industries being regulated.” [17]

The conflict of interest among scientists at the European Food Safety Authority
(EFSA) GMO Panel is quite explicit. According to Friends of the Earth, “One
member has direct financial links with the biotech industry and others have
indirect links, such as close involvement with major conferences organized
by the biotech industry. Two members have even appeared in promotional videos
produced by the biotech industry. . . . Several members of the Panel, including
the chair Professor Kuiper, have been involved with the EU-funded ENTRANSFOOD
project. The aim of this project was to agree [to] safety assessment, risk
management and risk communication procedures that would ‘facilitate
market introduction of GMOs in Europe, and therefore bring the European industry
in a competitive position.’ Professor Kuiper, who coordinated the ENTRANSFOOD
project, sat on a working group that also included staff from Monsanto, Bayer
CropScience and Syngenta.” The report concludes that EFSA is “being
used to create a false impression of scientific agreement when the real situation
is one of intense and continuing debate and uncertainty.” [18] This parallels
the deceptive façade at the FDA.

The pro-GM European Commission repeats the same ruse. According to leaked
documents obtained by Friends of the Earth, while they privately appreciate “the
uncertainties and gaps in knowledge that exist in relation to the safety of
GM crops . . . the Commission normally keeps this uncertainty concealed from
the public whilst presenting its decisions about the safety of GM crops and
foods as being certain and scientifically based.” Further, in private “they
frequently criticize the European Food Safety Authority (EFSA) and its assessments
of the safety of GM foods and crops, even though the Commission relies on these
evaluations to make recommendations to member states. . . [and] to justify
its decisions to approve new GM foods.” [19] For example, the Commission
privately condemned the submission information for one crop as “mixed,
scarce, delivered consecutively all over years, and not convincing.” They
said there is “No sufficient experimental evidence to assess the safety.” [20]

Evaluations miss most health problems

Although the body of safety studies on GM foods is quite small, it has verified
the concerns expressed by FDA scientists and others.

The gene inserted into plant DNA may produce a protein that is inherently
unhealthy. The inserted gene has been found to transfer into human gut bacteria
and may even end up in human cellular DNA, where it might produce its protein
over the long-term. Toxic substances in GM animal feed might bioaccumulate
into milk and meat products. Farmer and medical reports link GM feed to thousands
of sick, sterile, and dead animals. But there is not a single government safety
assessment program in the world that is competent to even identify most of
these potential health problems, let alone protect its citizens from the effects.
[21]

A review of approved GM crops in Canada by professor E. Ann Clark, for example,
reveals that 70% (28 of 40) “of the currently available GM crops . .
. have not been subjected to any actual lab or animal toxicity testing, either
as refined oils for direct human consumption or indirectly as feedstuffs for
livestock. The same finding pertains to all three GM tomato Decisions, the
only GM flax, and to five GM corn crops.” In the remaining 30% (12) of
the other crops tested, animals were not fed the whole GM feed. They were given
just the isolated GM protein that the plant was engineered to produce. But
even this protein was not extracted from the actual GM plant. Rather, it was
manufactured in genetically engineered bacteria. This method of testing would
never identify problems associated with collateral damage to GM plant DNA,
unpredicted changes in the GM protein, transfer of genes to bacteria or human
cells, excessive herbicide residues, or accumulation of toxins in the food
chain, among others. Clark asks, “Where are the trials showing lack of
harm to fed livestock, or that meat and milk from livestock fed on GM feedstuffs
are safe?” [22]

“A review of twelve reports covering twenty-eight GM crops - four soy,
three corn, ten potatoes, eight canola, one sugar beet and two cotton - revealed
no feeding trials on people. In addition, one of the GM corn varieties had
gone untested on animals. Some seventeen foods involved testing with only a
single oral gavage (a type of forced-feeding), with observation for seven to
fourteen days, and only of the substance that had been genetically engineered
to appear [the GM protein], not the whole food. Such testing assumes that the
only new substance that will appear in the food is the one genetically engineered
to appear, that the GM plant-produced substance will act in the same manner
as the tested substance that was obtained from another source [GM bacteria],
and that the substance will create disease within a few days. All are untested
hypotheses and make a mockery of GM proponents’ claims that the risk
assessment of GM foods is based on sound science. Furthermore, where the whole
food was given to animals to eat, sample sizes were often very low - for example,
five to six cows per group for Roundup Ready soy - and they were fed for only
four weeks.” [24]

Hidden information, lack of standards, and breaking laws

Companies claim that their submissions to government regulators are “confidential
business information” so they are kept secret. Some industry studies
that have been forced into the public domain through Freedom of Information
requests or lawsuits have been appalling in design and execution. This is due
in part to the lack of meaningful and consistent standards required for assessments.
Gurian-Sherman says of the FDA’s voluntary consultation, “Some
submissions are hundreds of pages long while others are only 10 or 20.” [25]
A Friends of the Earth report on US regulation and corporate testing practices
states, “Without standardization, companies can and do design test procedures
to get the results they want.” [26] Regulators also reference international
standards as it suits them. According to the Centre for Integrated Research
in Biosafety, for example, FSANZ “relaxed adherence to international
standards for safety testing when that better suited the Applicant’s
submitted work, and imposed international standards whenever that was a lower
standard than we recommended.” [27]

Regulators also break laws. The declaration of GRAS status by the FDA deviated
from the Food and Cosmetic Act and years of legal precedent. In Europe, the
law requires that when EFSA and member states have different opinions, they “are
obliged to co-operate with a view to either resolving the divergence or preparing
a joint document clarifying the contentious scientific issues and identifying
the relevant uncertainties in the data.” [28] According to FOE, in the
case of all GM crop reviews, none of these legal obligations were followed.
[29]

Humans as guinea pigs

Since GM foods are not properly tested before they enter the market, consumers
are the guinea pigs. But this doesn’t even qualify as an experiment.
There are no controls and no monitoring. Without post- marketing surveillance,
the chances of tracing health problems to GM food are low. The incidence of
a disease would have to increase dramatically before it was noticed, meaning
that millions may have to get sick before a change is investigated. Tracking
the impact of GM foods is even more difficult in North America, where the foods
are not labeled. Regulators at Health Canada announced in 2002 that they would
monitor Canadians for health problems from eating GM foods. A spokesperson
said, “I think it’s just prudent and what the public expects, that
we will keep a careful eye on the health of Canadians.” But according
to CBC TV news, Health Canada “abandoned that research less than a year
later saying it was ‘too difficult to put an effective surveillance system
in place.’” The news anchor added, “So at this point, there
is little research into the health effects of genetically modified food. So
will we ever know for sure if it’s safe?” [30]

Not with the biotech companies in charge. Consider the following statement
in a report submitted to county officials in California by pro-GM members of
a task force. “[It is] generally agreed that long- term monitoring of
the human health risks of GM food through epidemiological studies is not necessary
because there is no scientific evidence suggesting any long-term harm from
these foods.” [31] Note the circular logic: Because no long-term epidemiological
studies are in place, we have no evidence showing long-term harm. And since
we don’t have any evidence of long-term harm, we don’t need studies
to look for it.

What are these people thinking? Insight into the pro-GM mindset was provided
by Dan Glickman, the US Secretary of Agriculture under President Clinton.

“What I saw generically on the pro-biotech side was the attitude that
the technology was good, and that it was almost immoral to say that it wasn’t
good, because it was going to solve the problems of the human race and feed
the hungry and clothe the naked. . . . And there was a lot of money that had
been invested in this, and if you’re against it, you’re Luddites,
you’re stupid. That, frankly, was the side our government was on. Without
thinking, we had basically taken this issue as a trade issue and they, whoever ‘they’ were,
wanted to keep our product out of their market. And they were foolish, or stupid,
and didn’t have an effective regulatory system. There was rhetoric like
that even here in this department. You felt like you were almost an alien,
disloyal, by trying to present an open-minded view on some of the issues being
raised. So I pretty much spouted the rhetoric that everybody else around here
spouted; it was written into my speeches.” [32]

Fortunately, not everyone feels that questioning GM foods is disloyal. On
the contrary, millions of people around the world are unwilling to participate
in this uncontrolled experiment. They refuse to eat GM foods. Manufacturers
in Europe and Japan have committed to avoid using GM ingredients. And the US
natural foods industry, not waiting for the government to test or label GMOs,
is now engaged in removing all remaining GM ingredients from their sector using
a third party verification system. The Campaign for Healthier Eating in America
will circulate non-GMO shopping guides in stores nationwide so that consumers
have clear, healthy non-GMO choices. With no governmental regulation of biotech
corporations, it is left to consumers to protect themselves.

To learn how to opt-out of the eating GMOs and to find non-GM alternative
brands, visit www.responsibletechnology.org .

New Book Genetic Roulette Documents Serious Health Dangers

The sourcebook for the Campaign is the newly released Genetic Roulette: The
Documented Health Risks of Genetically Engineered Foods. With input from more
than 30 scientists over two years, it presents 65 health risks of GM foods
and why current safety assessments are not competent to protect us from most
of them. The book documents lab animals with damage to virtually every system
and organ studied; thousands of sick, sterile, or dead livestock; and people
around the world who have traced toxic or allergic reactions to eating GM products,
breathing GM pollen, or touching GM crops at harvest. It also exposes many
incorrect assumptions that were used to support GM approvals. Organizations
worldwide are presenting the book to policy makers as evidence that GM foods
are unsafe and need to be removed immediately.

But we don’t need to wait for governments to step in. We can make healthier
choices for ourselves, our families, and our schools now, and together we can
inspire the tipping point for healthier, non-GM eating in America. We believe
that this can be achieved within the next 24 months.

***********************************************

The GM crops sold in the US include soy (including soy lecithin used in chocolate
and thousands of other products as an emulsifier), corn (including high fructose
corn syrup), cottonseed and canola (both used in vegetable oil), Hawaiian papaya,
and a small amount of zucchini and crook-neck squash. There is also alfalfa
for cattle (the sale of which was halted by a federal judge on March 13, 2007),
GM additives such as aspartame, and milk from cows treated with GM bovine growth
hormone. There is not yet any GM popcorn, white corn or blue corn. And the
industry is threatening to introduce GM sugar from sugar beets next year. To
learn more, for online shopping guides and to find out how to get involved,
go to www.ResponsibleTechnology.org .

The Institute for Responsible Technology’s plans to achieve the tipping
point on GMOs through consumer education has inspired the Mercola.com Foundation
to match donations and membership fees to the Institute at this time. Please
help end the genetic engineering of our food supply by contributing to the
implementation of this important project.

Jeffrey M. Smith is the author of the newly released book, Genetic Roulette:
The documented health risks of genetically engineered foods. He is the director
of the Institute for Responsible Technology and the Campaign for Healthier
Eating in America, the international bestselling author of Seeds of Deception,
and the producer of the DVD Hidden Dangers in Kids’ Meals.

[5] Dan Quayle, “Speech in the Indian Treaty Room of the Old Executive
Office Building,” May 26, 1992.

[6] See Smith, Seeds of Deception; and for copies of FDA memos, see The Alliance
for Bio-Integrity, www.biointegrity.org

[7] Steven M. Druker, “How the US Food and Drug Administration approved
genetically engineered foods despite the deaths one had caused and the warnings
of its own scientists about their unique risks,” Alliance for Bio-Integrity,
http://www.biointegrity.org /ext- summary.html

[11] “Elements of Precaution: Recommendations for the Regulation of
Food Biotechnology in Canada; An Expert Panel Report on the Future of Food
Biotechnology prepared by The Royal Society of Canada at the request of Health
Canada Canadian Food Inspection Agency and Environment Canada” The Royal
Society of Canada, January 2001.

[12] Doug Gurian-Sherman, “Holes in the Biotech Safety Net, FDA Policy
Does Not Assure the Safety of Genetically Engineered Foods,” Center
for Science in the Public Interest, http://www.cspinet.org/new/ pdf /fda_report__final.pdf